Ebert C, Bieglmayer C, Igari J, Chan D, Torralba A, Müller C, Veys A, Bätz O, Dageförde S, Roth H J, Neumeier D, Assmann G, Banfi G M, Yvert J P
Boehringer Mannheim GmbH, Penzberg, Germany.
Wien Klin Wochenschr. 1998;110 Suppl 3:27-40.
6 assays for the assessment of thyroid function (TSH, FT4, T4, T-uptake, FT3 and T3) were targets of the International Multicenter Study on the random access analyzer Elecsys 2010. The aim of the study was to characterize the clinical performance of the assay in method comparison and reference range studies. The assays under evaluation were compared to a broad variety of radio isotopic and non-radio isotopic assays. They are suitable for serum and plasma samples. In case of TSH the study include 2nd and 3rd generation TSH procedures. In general, good to excellent correlations were found between the Elecsys and the respective routine methods. Systematic deviations were extraordinary low in case of TSH, FT4 and T4. Regarding the analysis of T3 and FT3 some systematic deviations in terms of standardization have been observed. Results of Elecsys T4 and Elecsys FT4 were independent of the serum total protein or serum albumin concentrations. In T3 and FT3 Elecsys the results of samples from NTI (non-thyroidal-illness) patients were decreased, reflecting the physiological situation in these patients. Studies using samples from healthy euthyroid as well as untreated hypo- and hyperthyroid individuals enabled us to assess the assays reference ranges.
评估甲状腺功能的6项检测指标（促甲状腺激素、游离甲状腺素、总甲状腺素、甲状腺摄取率、游离三碘甲腺原氨酸和总三碘甲腺原氨酸）是针对随机存取分析仪Elecsys 2010的国际多中心研究的目标。该研究的目的是在方法比较和参考范围研究中描述这些检测方法的临床性能。将评估的检测方法与多种放射性同位素和非放射性同位素检测方法进行了比较。它们适用于血清和血浆样本。对于促甲状腺激素，该研究包括第二代和第三代促甲状腺激素检测方法。总体而言，Elecsys检测方法与各自的常规方法之间发现了良好至优异的相关性。促甲状腺激素、游离甲状腺素和总甲状腺素的系统偏差极低。关于总三碘甲腺原氨酸和游离三碘甲腺原氨酸的分析，在标准化方面观察到了一些系统偏差。Elecsys总甲状腺素和Elecsys游离甲状腺素的结果与血清总蛋白或血清白蛋白浓度无关。在总三碘甲腺原氨酸和游离三碘甲腺原氨酸的Elecsys检测中，非甲状腺疾病（NTI）患者样本的结果降低，反映了这些患者的生理状况。使用健康甲状腺功能正常以及未经治疗的甲状腺功能减退和亢进个体的样本进行的研究使我们能够评估这些检测方法的参考范围。
